Launching Operational Excellence (OPEX) constitutes a true challenge for every manufacturing organization. Changing the habits and behavior of people, making them to leave the beaten track and ultimately changing their mindset to continuous improvement is a real management task and demands leaders to be charismatic, encouraging and tenacious. This especially holds true for the highly regulated pharmaceutical industry and its heritage of reluctance to change. Nevertheless, most large pharmaceutical organizations based in advanced economies have launched an OPEX program in an effort to holistically improve their operations since the turn of the millennium. Moreover, after the first results and realized benefits have been publicized, the transformational concept found its way to small and medium-sized pharmaceutical manufactures and did not stop to enter domestic organizations of the so called emerging markets. These markets distinguish substantially from advanced economies and their unique setup make it nearly impossible, to transfer the concepts that work perfectly in western organizations to domestic emerging market manufacturers without any localized adaptions.
This dissertation suggests an approach how domestic pharmaceutical manufacturers in emerging markets can design their individual OPEX program that fits to their specific internal and external requirements.
First, two literature reviews examine the knowledge base on emerging markets and OPEX. These reviews provide deep insights into what constitutes an emerging market and list the major influences of these markets towards domestic manufacturing sites. Furthermore, the philosophy and elements of OPEX are analyzed and critically reflected within a pharmaceutical and emerging market context.
Second, a benchmarking of OPEX practices of 267 pharmaceutical manufacturing sites allows the comparison of sites in advanced and emerging markets. Subsequent case studies and workshop results in two Sub-Saharan African countries give first-hand impressions of the current status of pharmaceutical operations in selected emerging markets.
Third, based on the findings the requirements for a transformation of a domestic pharmaceutical manufacturing site towards OPEX are derived.
Finally, an OPEX Architecture is designed to support the focused manufacturing sites in the development of their own OPEX program and an underlying model. The discussion is enhanced by anecdotal evidence from interviews with OPEX leaders in emerging markets of various multinational pharmaceutical organizations.